跳至主要内容
临床试验/NCT05370339
NCT05370339已完成不适用

Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Number of nocturnal awakenings per week

研究概览

简要总结

The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with T1D at least 3 months
  • Receive clinical care at the Barbara Davis Center

排除标准

  • Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
  • Participation in an interventional research protocol
  • Unable to complete study procedures

结局指标

主要结局

Number of nocturnal awakenings per week

时间窗: One week per participant

We will identify the number of nocturnal awakenings per week for comparison of those with insufficient sleep identified by actigraphy watch to those with sufficient sleep.

Assessment of facilitators and barriers to good sleep quality and duration

时间窗: One week per participant

Qualitative interviews will be conducted and analyzed for themes to identify causes of sleep disruptions and any potential barriers or facilitators to improving sleep health.

次要结局

  • Identification of common causes of sleep disruptors in adolescents with type 1 diabetes(One week per participant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验